ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS— 510(k) K852727

Name: FDA 510(k) clearance K852727
Creator: U.S. Food and Drug Administration
Published: 1985-07-15

Substantially Equivalent

The Huxley Instrument Corp.

FDA 510(k) clearance K852727 for ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS, Substantially Equivalent on 1985-07-15. Applicant: The Huxley Instrument Corp.. Device class: 1.

Clearance details

Applicant: The Huxley Instrument Corp.
Product code: Code HTD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-06-26
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Penn Yan, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTD

product code HTD

Malfunction: 892
Total: 892

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.